Randomized Controlled Trials and Consolidated Standards of Reporting Trials “Consort” 2010- 2019, Pakistan:

Rozina Shahadat Khan; Romaisa Siddique; Asma Ali; Fatawal Tahir; Sunair Siddique Khan; Sajid Malik

doi:10.29054/apmc/2024.1601

Rozina Shahadat Khan Associate Professor, Department of Community Medicine, Post Graduate Medical Institute, Lahore Pakistan http://orcid.org/0000-0001-7651-652X
Romaisa Siddique Student, Lahore School of Economics, Lahore Pakistan
Asma Ali Senior Demonstrator, Department of Community Medicine, Post Graduate Medical Institute, Lahore Pakistan
Fatawal Tahir Women Medical Officer, Combined Military Hospital, Sialkot Pakistan
Sunair Siddique Khan Student, Coventry University, United Kingdom
Sajid Malik Specialty Doctor, Upper GI Surgery Croydon University Hospital, London United Kingdom

DOI: https://doi.org/10.29054/apmc/2024.1601

Keywords: Research transparency, Randomized controlled trials (RCTs), Consolidated standards of reporting Trials (Consort), Random allocation and Interventional studies

Abstract

Background: Contrary to general practice, research transparency and reliability of published material is related to the Reporting Guidelines like endorsement of CONSORT Statement for reporting Randomized Controlled Trials. Objective: To assess the compliance of Randomized Control Trials (RCTs) with the Consolidated Standards of Reporting Trials (CONSORT) conducted and reported from Pakistan. Study Design: Systematic Review. Settings: NA. Duration: Six months after ethical clearance. Methods: Systematic Review with 781 RCTs published from 2010-2019 in 44 online Pakistani journals retrieved from PakMediNet. CONSORT checklist has been used to verify whether the items have been followed or not and if followed then to which extent by calculating Summation score drawn from the CONSORT checklist items by allotting mark for each item. Individual RCT suggests ≥70% adherence which is considered to have Adequate Compliance (AC). Results: The mean score achieved was 16.85/37 (45.54%). A statistically significant association was found between Funding and Adherence. The publications have increased over the years with only 15/781(1.9%) RCTs published in 2010 to 138/781(17.7%) in 2019 but the Adherence to the CONSORT remained almost the same with the mean overall yearly Adherence of 45.54 % of individual articles. Conclusion: The use of CONSORT statement has not significantly improved the reporting of trials due to inadequate adherence to guidelines, hence reinforcing use of statement for the reporting of trials. Nonetheless, statistically significant association of Funding and Adherence has supported Funding to achieve Adequate Compliance to CONSORT.